B-Cell Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma
Conditions
Brief summary
This is a Phase I open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of tiragolumab administered as a single agent or in combination with atezolizumab and/or daratumumab or rituximab in participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin lymphoma (NHL).
Detailed description
In the Phase Ia part of the study, tiragolumab is administered as a single agent in participants with R/R MM or R/R NHL. In the Phase Ib part of the study, tiragolumab is administered in combination with atezolizumab and/or daratumumab in participants with R/R MM or with rituximab in participants with R/R NHL.
Interventions
DRUGTiragolumab
Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)
Administered by SC injection 1800 mg/30,000 U rHuPH20 weekly for a total of 6 doses, then every 3 weeks for a total of 16 doses (first dose given at Week 7), then every 4 weeks from Week 55 onward until disease progression
DRUGRituximab
Administered for a total of 8 doses. Rituximab will be administered by IV infusion for the first dose at a dose of 375 mg/m\^2. After administration of at least one full infusion of IV rituximab, the SC formulation of rituximab (rituximab and rHuPH20) may be used for the remaining doses per institutional guidelines. SC rituximab will be administered at a dose of 1400 mg rituximab/23400 U rHuPH20 once weekly (QW).
DRUGAtezolizumab
Administered by IV infusion at a fixed dose of 1200 mg Q3W
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria (All Participants): * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of \>/= 12 weeks Inclusion Criteria Specific to Arms A, C and E (R/R MM): * Arm A only: Must have R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies * Arms C and E only: Participants with R/R MM who have received at least 3 prior lines of therapy. * Measurable disease defined by laboratory test results. Inclusion Criteria Specific to Arms B and D (R/R NHL): * Participants with histologically confirmed B-cell NHL who have relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists. * Must have at least one bi-dimensionally measurable lesion.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events | Through study completion, an average of 1 year | Determined according to the NCI CTCAE Version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Atezolizumab | Cycles 1, 2, 3, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) | — |
| Objective Response Rate (ORR) for R/R MM | Through study completion, an average of 1 year | Proportion of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR), as defined by the International Myeloma Working Group (IMWG) criteria |
| Serum Concentration of Tiragolumab | Cycles 1, 2, 3, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) | — |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab | Cycles 1, 2, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) | — |
| Percentage of Participants With ADAs to Atezolizumab | Cycles 1, 2, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) | — |
| ORR for R/R NHL | Through study completion, an average of 1 year | Proportion of participants with a CR or PR on two consecutive occasions \>/= 4 weeks apart, according to the Lugano classification |
Countries
South Korea, United States
Outcome results
None listed